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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K980131
Device Name ALEX TA2 ERASER
Applicant
Light Age, Inc.
Two Riverview Dr.
Somerset,  NJ  08873
Applicant Contact RICK FROST
Correspondent
Light Age, Inc.
Two Riverview Dr.
Somerset,  NJ  08873
Correspondent Contact RICK FROST
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/15/1998
Decision Date 02/17/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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